CONCORDE BULLET CAGE SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K103488
Device Name CONCORDE BULLET CAGE SYSTEM
Applicant
JOHNSON AND JOHNSON
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact kevin g stevens
Correspondent
JOHNSON AND JOHNSON
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact kevin g stevens
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Codes
MQP   ODP  
Date Received 11/26/2010
Decision Date 03/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No